Engineer, upstream cell culture & harvest; JP

Overview

Job Title: Engineer, upstream cell culture & harvest (JP12822)

Location: Thousand Oaks, CA. 91320

Business Unit: ATO Development PE II

Employment Type: Contract

Duration: 1+ years with possible extension or conversion to FTE

Rate: $38 - $42 / hr

Posting Date: 6/5/24

Notes: On site minimum 3 days per week. Specifically looking for upstream cell culture & harvest experience.

3 Key Consulting is hiring! We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team at our client’s Thousand Oaks facility. Providing process engineering support for human therapeutic products in clinical development through commercial production.

The Engineer will apply cell culture and/or purification process engineering knowledge in support of technology transfer and clinical/commercial drug substance manufacturing in an innovative manufacturing suite using single-use technology. Will partner with manufacturing, quality, analytical, and bench scientists to support a highly dynamic manufacturing facility.

We are specifically looking for upstream cell culture & harvest experience.

• Must have biotech background/experience, plus must have cell culture and/or purification experience
• Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
• GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)
• Specifically looking for upstream cell-culture experience

• Under guidance of senior staff, the Engineer performs the following:
  Transfer purification drug substance processes and performs process improvements from the laboratory into the manufacturing facility
• Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation
• Offer process validation support for late stage commercial processes
• Provide routine process monitoring and troubleshooting
• Execute data trending and statistical process analysis
• Support technical direction for process related deviations, CAPAs and change controls
• Identify and support process related operational excellence opportunities
• Represent process development and collaborate with other functions such as Manufacturing, Quality, and Regulatory

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)
• GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Supplement additional workload on team.

Phone/ Webex

We invite qualified candidates to send your resume to  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website  You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.